A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular Pressure
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | December 2010 |
End Date: | November 2012 |
Contact: | Quintiles Ltd |
Phone: | 44 1344 708000 |
A Double Masked, Placebo Controlled, Randomised, Parallel Group Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-Ocular Pressure
The purpose of this study is to evaluate the efficacy of systemically administered AZD4017,
compared with placebo, over a 28-day period in patients with raised intra-ocular pressure
(IOP).
Inclusion Criteria:
- Must have a diagnosis of intra-ocular hypertension (raised IOP), or primary
open-angle glaucoma (POAG), with IOP >20 mmHg and ≤36 mmHg in the study eye, and is
currently prescribed a stable dose of a single anti-glaucoma medication that began at
least 30 days prior to the screening visit; OR
- Must have a diagnosis of intra-ocular hypertension (raised IOP), defined as an IOP
≥22 mmHg and ≤36 mmHg in the study eye while not on anti-glaucoma medication
- Male patients must be willing to use barrier contraception with spermicide, ie,
condoms, from the day of first dosing until 3 months after dosing with IP
- Placebo treatment for duration of the study must not be considered detrimental to the
patient
Exclusion Criteria:
- Have uncontrolled intra-ocular hypertension (>36 mmHg)
- Have experienced a significant visual field loss or showed evidence of progressive
visual field loss within the last year (as defined by >1 dB/yr average loss or vision
threatening new defect)
- Have had severe eye trauma at any time
We found this trial at
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